Drug-Drug Interactions Between Rifapentine and Dolutegravir in HIV/LTBI Co-Infected Individuals

  • STATUS
    Not Recruiting
  • days left to enroll
    49
  • participants needed
    72
  • sponsor
    National Institute of Allergy and Infectious Diseases (NIAID)
Updated on 20 July 2022
ct scan
platelet count
body mass index
total bilirubin
hysterectomy
absolute neutrophil count
antiretroviral
antiretroviral agents
antiretroviral therapy
hiv test
dolutegravir
western blot
interferon
isoniazid
chest radiograph
urine test
HIV Vaccine
investigational new drug
skin test
tuberculin test
immune globulin
antibody test
interferon-gamma release assay
hiv-1 infection
rifapentine
hiv-1 rna measurement
hiv-1 antigen

Summary

This study will evaluate the potential drug-drug interactions between dolutegravir (DTG) and steady state rifapentine (RPT) when RPT is given with isoniazid (INH) daily for 4 weeks (1HP) as part of treatment for latent TB infection (LTBI) in HIV-1 and LTBI co-infected individuals.

Description

The purpose of this study is to evaluate the potential drug-drug interactions between dolutegravir (DTG) and steady state rifapentine (RPT) when RPT is given with isoniazid (INH) daily for 4 weeks (1HP) as part of treatment for latent TB infection (LTBI) in HIV-1 and LTBI co-infected individuals.

Participants will receive study-provided INH and RPT once daily for 4 weeks (1HP). During the 1HP treatment, DTG will be administered twice daily in Arm 1, and once daily in Arm 2.

At study entry, all participants must also be on DTG-based antiretroviral (ARV) treatment with 2 nucleoside reverse transcriptase inhibitors (NRTIs) (excluding tenofovir alafenamide [TAF]) during the study. In Arm 1 participants, DTG 50 mg will be administered twice daily; the morning dose from non-study ARV supply and the evening dose from study supply. In Arm 2 participants, DTG 50 mg will be administered once daily, in the morning, from non-study ARV supply.

Participants must receive pyridoxine (vitamin B6) with each dose of INH based on the current local, national, or international dosing guidelines. NRTI therapy and pyridoxine (vitamin B6) will not be provided by the study.

The study will begin enrollment with Arm 1. Opening of Arm 2 will depend on assessment of DTG pharmacokinetics (PK) data from participants in Arm 1.

The majority of participants will be on study for 6 weeks (a 4-week on-study treatment period and a 2-week follow-up period). Some participants may be on study for up to 11 weeks if the on-study treatment duration has been extended or if participants need to have additional follow-up visits to measure viral load.

Details
Condition HIV Infection, LTBI
Treatment Dolutegravir (DTG), Isoniazid (INH), Rifapentine (RPT), Pyridoxine (vitamin B6), Antiretroviral Therapy (ART)
Clinical Study IdentifierNCT04272242
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last Modified on20 July 2022

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